Evaluating LM-302 with Candonilimab and Capecitabine for Advanced Gastric Cancer
Official title: A Phase II Study Evaluating the Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
Run by Shanghai Zhongshan Hospital · NCT06587425 · Data updated 2026-11-12
This study is testing a new combination of treatments for people with advanced stomach cancer to see if it can help them fight the disease better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Drugs / interventions | radiation, methotrexate, cyclophosphamide, prednisone, Candonilimab, cadonilimab |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | July 31, 2024 |
| Main results expected | July 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | September 19, 2024 |
| Trial ID | NCT06587425 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with unresectable, recurrent, or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma.
✕Probably not a fit
Patients with resectable tumors or those who do not express CLDN18.2 may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the efficacy and safety of LM-302, an antibody-drug conjugate targeting CLDN18.2, in combination with cadonilimab, an immune checkpoint inhibitor, and capecitabine for first-line treatment in patients with unresectable advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma. The study aims to leverage the synergistic effects of these therapies to enhance anti-tumor activity. Participants must have confirmed CLDN18.2-positive tumors and may have received prior treatments, provided they meet specific criteria regarding disease progression and treatment-related toxicity. The trial is conducted at Zhongshan Hospital in Shanghai.
Why it matters
Potential benefit: If successful, this treatment combination could provide a new effective option for patients with advanced gastric cancer.
How similar studies have gone: Other studies have shown promising results with similar combinations of antibody-drug conjugates and immune checkpoint inhibitors, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * The subjects fully understand the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participate as participants, and sign an informed consent form (ICF) before any procedures begin * The subject must have locally advanced or metastatic gastric cancer or gastroesophageal junction cancer that cannot be surgically removed, and the histopathological examination confirms it to be simple adenocarcinoma * Permissible Previous Treatment: Participants with gastric cancer or gastroesophageal junction cancer who have previously received adjuvant or neoadjuvant treatment and have experienced clinical disease progression at least 6 months after the last administration are eligible for inclusion. (Note: The treatment-related toxicity of oxaliplatin in previous adjuvant or neoadjuvant treatments must be restored to the National Cancer Institute \[NCI\] General Terminology Standard for Adverse Events \[CTCAE\] v5.0 Level 1 before enrollment) * CLDN18.2 positivity: Provide sufficient tissue markers for Claudin18.2 immunohistochemistry testing. Claudin18.2 immunohistochemistry expression ≥ 10% is confirmed as positive, and\<10% is recorded as negative * According to RECIST v1.1 standard, there should be at least one measurable lesion * ECOG physical state ≤ 1 * Expected lifespan\>3 months * Adequate renal function: creatinine (Cr) ≤ 1.5 x upper limit of normal (ULN) and glomerular filtration rate (GFR) ≥ 60mL/min/1.73 m2; * Sufficient liver function: Total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5 × ULN (if there is liver metastasis, AST and ALT ≤ 5 × ULN, total bilirubin ≤ 2.5 × ULN); * Adequate bone marrow reserve: Platelet count (PLT) ≥ 100 × 109/L, absolute neutrophil count (ANC) ≥ 1.5 × 109/L, hemoglobin ≥ 9 g/dL (no adjuvant therapy such as EPO, G-CSF, or GM-CSF has been received within 14 days, and no blood transfusion including red blood cells and platelets has been received at least 7 days before the first administration); Prothrombin time/activated partial thromboplastin time (PT/PTT)\<1.5 x ULN; * Male or female aged ≥ 18 years old. Exclusion Criteria: * Known HER2 positive gastric cancer/adenocarcinoma of the gastroesophageal junction. HER2 positivity refers to HER2 amplification that requires confirmation from ISH if the HER2 immunohistochemistry test result is 3+and the immunohistochemistry test result is 2+ * Has undergone major surgery or radiation therapy within 4 weeks prior to enrollment; * Active, known or suspected autoimmune diseases * Congestive heart failure or symptomatic coronary artery disease within 3 months prior to enrollment * A cerebrovascular accident occurred within the past 6 months * Clinically significant bleeding, bleeding events, or thromboembolic diseases occur within 6 months * History of intestinal perforation * Have a history of (non infectious) pneumonia requiring steroid treatment or currently suffer from pneumonia * Known history of human immunodeficiency virus (HIV) infection. Subjects with active hepatitis B or active hepatitis C. (Unless receiving antiviral therapy for at least 14 days prior to the first study drug administration and passing hepatitis B virus (HBV) DNA titer testing (not exceeding 500 IU/mL or 2500 copies \[cps\]/mL) and hepatitis C virus (HCV) RNA testing (not exceeding the lower limit of the assay), eligible for inclusion in the trial and willing to continue receiving effective antiviral therapy during the study period); * Severe impairment of lung function or history of interstitial lung disease * Diagnosed with concurrent malignant tumors within the past 2 years (except for fully treated non melanoma skin cancer, superficial bladder transitional cell carcinoma, and cervical carcinoma in situ \[CIS\]) or any currently active malignant tumor * Previous or current evidence suggests that there may be confusion with the research results, interference with the participant\'s participation in the entire study process, any conditions, treatments, or laboratory abnormalities, or the researcher believes that participating in this study is not in the best interest of the participant * Pregnancy test positive within 7 days before the first administration, or women of childbearing age who are in lactation period * Individuals with known mental illnesses or disorders that may affect trial compliance * Subjects who take systemic corticosteroids (\>10 mg daily prednisone equivalent) or other systemic immunosuppressive drugs (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor drugs) within 2 weeks prior to the first medication are allowed to use local, ocular, intra-articular, intranasal, and inhaled corticosteroids * Subjects with a known history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, Guillain Barre syndrome, multiple sclerosis, or glomerulonephritis, excluding autoimmune hypothyroidism treated with stable dose hormone replacement therapy * Individuals with a history of previous immunodeficiency, including those with other acquired or congenital immunodeficiency diseases, or those with a history of organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation The researcher determined that there are other situations that are not suitable for participation in this study * The researcher determined that there are other situations that are not suitable for participation in this study
Where it's running
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Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Principal investigator: Tianshu Liu, Doctor — Fudan University
- Study coordinator: Yiyi Yu, Doctor
- Email: yu.yiyi@zs-hospital.sh.cn
- Phone: +86 138 1673 0912
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Candonilimab with Fruquintinib and Paclitaxel Albumin-Bound as second-line treatment for advanced gastric cancer
This phase 2 trial tests whether adding candonilimab to fruquintinib and nab-paclitaxel helps people with advanced gastric or gastroesophageal junction cancer who progressed after first-line therapy.
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QLS31905 plus CAPOX vs sintilimab plus CAPOX as first-line treatment for gastric/GEJ cancer
This phase 3 trial tests whether QLS31905 with CAPOX works as well as or better than sintilimab with CAPOX for first-line treatment in CLDN18.2-positive, PD-L1 CPS < 5, HER2-negative unresectable or metastatic gastric/GEJ cancer.
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Perioperative chemo with low-dose radiotherapy and tislelizumab for locally advanced gastric/GEJ cancer
This trial tests whether adding low-dose radiotherapy and tislelizumab to perioperative chemotherapy helps people with resectable locally advanced gastric or gastroesophageal junction cancer.
-
HLX43 (an anti-PD-L1 antibody–drug conjugate) for advanced stomach or gastroesophageal junction adenocarcinoma
This will try different IV doses of HLX43 to see if it helps adults with advanced stomach or gastroesophageal junction adenocarcinoma who have progressed after prior therapy.
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Utidelone plus fluoropyrimidine-and-platinum chemotherapy for first-line gastric or gastroesophageal junction adenocarcinoma
This trial tests whether adding utidelone capsules to standard fluoropyrimidine-and-platinum chemotherapy helps people with untreated locally advanced or metastatic stomach or gastroesophageal junction adenocarcinoma.
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Treatment of advanced gastric, pancreatic, and biliary tract cancers with Spevatamig
This study is testing a new treatment called Spevatamig for people with advanced stomach, pancreatic, or bile duct cancers to see if it works better alone or with other cancer therapies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.